Fractional Head of Quality Services
Quick Navigation: Overview • Challenges • Typical Engagement • Our Approach • Client Profile
Service Overview
Fractional Head of Quality services provide executive-level quality and compliance oversight for life sciences organizations that need strategic leadership without full-time headcount commitment. We build quality infrastructure that satisfies investors, regulators, and commercial partners while scaling appropriately with organizational maturity and revenue stage.
Common Challenges
Organizations struggle with quality gaps that emerge during investor diligence, regulatory submissions requiring systematic quality documentation that doesn’t exist, and inspection findings that expose lack of quality leadership and oversight. Specific situations requiring fractional quality leadership include:
Early-stage companies building first quality management systems where founders have scientific expertise but lack regulatory and quality infrastructure knowledge to satisfy investor due diligence or regulatory submission requirements. Pre-revenue organizations needing quality leadership to prepare for commercial launch, regulatory submissions, or ISO certification without budget for full-time quality executive.
Companies between permanent quality leaders where departure of VP Quality or similar role creates leadership gap requiring immediate coverage to maintain compliance status and support ongoing operations. Fast-scaling organizations where explosive growth requires quality infrastructure development faster than permanent hiring processes can deliver leadership.
Regulatory inspection response where 483 observations, warning letters, or other findings require executive-level quality oversight to direct systematic remediation and demonstrate commitment to compliance. Investor preparation activities where companies need quality system maturity demonstration for Series A/B funding rounds, M&A due diligence, or strategic partnership negotiations.
Technology vendor quality systems where GxP software, medical device, or digital health companies need quality frameworks appropriate for their product but lack internal expertise in regulated environment requirements. Board-level quality representation where executive teams need quality and regulatory strategic counsel for business decisions affecting compliance status or market access.
ISO certification initiatives requiring executive sponsorship and strategic oversight beyond what project teams or consultants can provide without organizational authority and decision-making responsibility.
Most quality system failures in early-stage organizations occur because quality is treated as administrative function rather than strategic business capability that enables funding, regulatory approval, and commercial success.
Current Role
Fractional Head of Quality, CellPort Software (3+ years) Leading quality, information security, and regulatory compliance for GxP cell and gene therapy software platform. Responsibilities include:
- ISO 27001 certification achievement and maintenance
- QMS design and continuous improvement for software development and client services
- Risk-based software validation strategy using CSA and GAMP 5 principles
- Cross-functional quality integration with engineering, operations, and executive teams
- Strategic quality counsel supporting product development and commercial growth
Typical Engagement
Duration: 3-12 months for defined milestones, ongoing for sustained quality leadership, can transition to permanent hire as organization scales
Time commitment: 10-20 hours per week depending on organizational complexity and milestone intensity
Deliverables: Quality strategy, QMS infrastructure, regulatory submission support, inspection readiness, ISO certification achievement, executive-level quality representation
Client involvement: Direct reporting relationship to CEO or Board, regular executive team participation, quality function oversight authority
Engagement model: Retainer-based with defined scope and deliverables, structured to scale up or down based on organizational needs and milestone timelines
What Fractional Quality Leadership Provides
1. Strategic Quality Planning We develop quality strategies aligned with business objectives, regulatory requirements, and investor expectations rather than generic compliance programs disconnected from commercial reality.
2. QMS Infrastructure Development We build quality management systems appropriate for organizational maturity and risk profile, ensuring frameworks scale with business growth without requiring complete redesign.
3. Regulatory Submission Support We provide executive oversight for FDA 510(k), De Novo, or software submissions, EMA applications, and other regulatory filings requiring quality system demonstration and leadership accountability.
4. Inspection Readiness and Response We prepare organizations for regulatory inspections, lead inspection response activities, and direct systematic remediation of findings with executive authority and accountability.
5. Quality Culture Development We establish quality mindset across organizations where quality hasn’t historically been prioritized, ensuring compliance becomes integrated into business operations rather than competing priority.
6. Board and Investor Representation We provide quality and regulatory expertise at board level, helping executive teams make informed decisions affecting compliance status, market access, and commercial partnerships.
7. Permanent Hire Transition Support We can support recruitment, onboarding, and knowledge transfer when organizations are ready for full-time quality leadership, ensuring continuity and minimizing disruption.
Integration Points
Fractional Head of Quality role connects with all organizational functions - providing executive sponsorship for quality initiatives, regulatory strategy for commercial planning, compliance oversight for operations, and quality counsel for technology development.
Role supports fundraising activities by demonstrating quality maturity to investors, enables regulatory submissions through systematic quality documentation, and provides audit readiness for certification and inspection activities.
Client Profile
Early-stage life sciences organizations building quality infrastructure, pre-revenue companies preparing for commercial launch or regulatory submissions, organizations between permanent quality leaders, or companies requiring executive-level quality expertise without full-time headcount commitment. Particularly valuable for biotech startups, medical device companies, digital health organizations, and GxP software vendors where quality leadership gap threatens funding, regulatory approval, or commercial partnerships.
Ready to discuss fractional quality leadership? Contact us to explore how strategic quality oversight can enable your business objectives while maintaining compliance.
Connect with Kevin Shea on LinkedIn for ongoing insights on quality leadership and regulatory strategy.